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8 DRUG DELIVERY INNOVATIONS YOU SHOULD KNOW

July 20, 2023 By Sean Whooley

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Innovations in drug delivery never stop, and over the past 12 months or so a
wide variety have been in the spotlight.

Constant progress continues in the diabetes space, both in the form of insulin
delivery and other drug delivery methods. Elsewhere, we see implants, patches,
syringes and more showcasing the many ways we can deliver therapeutics.

About a year ago, we clued in readers to a list of six drug delivery innovations
they should know. Here, we provide a couple of updates on those and try to
introduce a few more developments that you should know:


THE LATEST IN AUTOMATED INSULIN DELIVERY TECH

Automated insulin delivery represents one of the most high-profile markets in
drug delivery, with the technology providing potentially life-saving therapy for
people with diabetes.



The Mobi automated insulin pump with the accompanying mobile app [Image courtesy
of Tandem Diabetes Care]Last year’s roundup included the FDA-cleared Omnipod 5
automated insulin delivery system from Insulet. At the time, the Medtronic
MiniMed 780G had not yet been cleared, although that changed in April.



There’s still plenty of innovation going on in this market, and a few more
automated insulin delivery systems made waves since.

Earlier this month, Tandem Diabetes Care won FDA clearance for its new Tandem
Mobi automated insulin delivery system. Tandem says Mobi, which is fully
controllable from a mobile app, is the world’s smallest durable AID system. It
features a 200-unit insulin cartridge and an on-pump button to provide an
alternative to phone control for insulin boluses. It comes in at less than half
the size of the existing Tandem pump system, the t:slim X2 pump.

In May, the FDA cleared the Beta Bionics iLet ACE automated insulin pump and
iLet dosing decision software. Beta Bionics’ iLet Bionic Pancreas uses an
adaptive, closed-loop algorithm. It initializes with the user’s body weight and
requires no additional insulin dosing parameters. The algorithm removes the need
to manually adjust insulin pump therapy settings and variables.

While Omnipod 5 marked Insulet’s progress in automated insulin delivery last
year, the company is already picking up steam with another offering. In April,
the FDA cleared Omnipod GO — a long-acting insulin delivery system for the
basal-only insulin population.

Keep an eye out for Tidepool Loop (partnered with BD diabetes spinoff Embecta)
and Ypsomed (partnered with Abbott and Dexcom CGMs).


INSULIN PEN ADD-ONS



The InsulCheck Dose device. [Image courtesy of Innovation Zed]For those who
don’t use automated insulin pumps and want to treat their diabetes in other
ways, plenty of other innovations came to the fore recently.



Insulin injector pens are one big piece of the market, and two recent
innovations improving them are worth touching on.

In December 20222, Biocorp won FDA 510(k) clearance for its Mallya device that
connects insulin pens. The Mallya smart sensor attaches directly to insulin pen
injectors to make them connected devices. It automatically collects and records
key treatment information and transmits it to a dedicated digital application.
That data includes selected insulin units, date and time of injection.

Innovation Zed makes a similar device, receiving CE mark approval in February
for InsulCheck Dose. The company designed InsulCheck Dose as a single-unit
add-on device for pen injectors. It automatically captures dose value dialed,
injection event time stamps and temperature. The device also captures mounting
and unmounting events.


ALTERNATIVE DIABETES THERAPIES UTILIZING DRUG DELIVERY METHODS

Aside from insulin delivery, companies are developing innovative alternatives to
manage and treat diabetes.

Vivani Medical’s NanoPortal technology is an implant for steady medication
delivery over extended periods of time. The company aims to guarantee correct
doses for patients while mitigating safety concerns around fluctuating drug
release profiles. The technology can also deliver large hydrophilic molecules,
including peptides and proteins. The company believes this enables a broader
range of therapeutic applications.

Vivani’s NanoPortal technology [Image courtesy of Vivani]

Vivani’s targeted conditions for this technology include type 2 diabetes,
non-alcoholic steatohepatitis (NASH) and obesity.

Sernova has been making progress on its Cell Pouch System, an implantable and
scalable medical device that forms a natural environment in the body for the
long-term survival and function of therapeutic cells. Those cells release
necessary proteins or factors missing from the body to treat chronic diseases,
including insulin-dependent diabetes.

Keep your eyes out for a collaboration between Humacyte and JDRF, which are
developing a biovascular pancreas (BVP).

They aim to advance the development of Humacyte’s BVP for treating type 1
diabetes. Humacyte designed its BVP to deliver insulin-producing islets using
its investigational, tissue-engineered blood vessel. The company calls it the
Human Acellular Vessel (HAV).


EAR TUBES WITH LIQUID-INFUSED MATERIALS FOR TREATING EAR INFECTIONS

A research collaboration found a potential drug delivery innovation to improve
outcomes for ear tubes known as tympanostomy tubes (TTs). This research came out
of the Wyss Institute for Biologically Inspired Engineering at Harvard
University, Harvard John A. Paulson School of Engineering and Applied Sciences
(SEAS), and Massachusetts Eye and Ear (MEE) in Boston.

Using TTs fabricated from a liquid-infused material — called iTTs — researchers
co-optimized difficult-to-reconcile functions. These include fast drug delivery
into the middle ear and fast drainage out, resistance against water crossing
from the outside into the middle ear, and preventing bacterial and cell adhesion
to tubes.

The researchers used chinchillas for an in vivo model relevant to the human ear
to compare the iTTs’ performance against traditional TTs. Chinchillas are the
gold standard for studying middle ear diseases and treatments, the team said,
because chinchillas and humans have a similar frequency range of hearing and
similarly sized tympanic membranes.

The ITTs preserved hearing and enabled easy and reliable dosing of antibiotic
ear drops to the middle ear compared to conventional tubes, the researchers
said.


MICRON BIOMEDICAL’S NEEDLE-FREE DRUG DELIVERY TECH



[Image from Micron Biomedical website]Atlanta-based Micron Biomedical develops
dissolvable, microarray-based products to simplify drug delivery and vaccines.



The patented microarray technology enables the administration of drugs and
vaccines that require cold storage and administration within minutes.  It can be
self-administered or caregiver-administered.

Micron says its technology simplifies transport, storage and administration
while eliminating traditional injection sharps waste. Completed trials
demonstrated clinical efficacy and strong patient preference, according to the
company.

In May, Micron announced that it added $3 million to its Series A fundraising
round, bringing the round’s total to $17 million.


MIT’S TRANSDERMAL DRUG DELIVERY PATCH

Researchers at MIT potentially found a way to address the difficulties of
transdermal drug delivery through a new wearable patch.



The ultrasound patch developed by MIT researchers for targeted drug delivery
[Image courtesy of MIT]The team thinks the skin can enable drugs to travel
directly to where they’re needed. That offers benefits in wound care, pain
relief and more. But the outer layer of the skin is a tough barrier that
prevents most small molecules from passing through.



To address this, the researchers developed a wearable patch that applies
painless, ultrasonic waves to the skin. This creates tiny channels that drugs
can pass through, potentially enabling treatments for skin conditions. The
researchers believe they can adapt the technology to deliver hormones, muscle
relaxants and other drugs.

Their patch design features several disc-shaped piezoelectric transducers that
convert electric currents into mechanical energy. Each disc is embedded in a
polymeric cavity that contains drug molecules dissolved in a liquid solution.
When the current is applied to the piezoelectric elements, it generates pressure
waves in the fluid. That, in turn, makes bubbles that burst against the skin,
producing microjets of fluid that can penetrate the skin’s outer layer.

The MIT team says the latest version of their device enables drugs to penetrate
a few millimeters into the skin. This makes the approach useful for drugs that
act locally within the skin. Those include niacinamide or vitamin C for treating
age spots or other dark spots, and topical drugs used to heal burns.


PRE-FILLED SYRINGES

While many of these drug delivery offerings represent potential new avenues, the
well-known pre-filled syringe continues to evolve.



The PosiFlush SafeScrub syringe [Image courtesy of BD]BD received clearance for
its PosiFlush SafeScrub pre-filled syringe and introduced it to select customers
in October 2022. The PosiFlush SafeScrub syringe has an integrated disinfection
unit to reinforce compliance with infection prevention guidelines and simplify
nursing workflow.



BD built the disinfection unit into the tip cap of the  syringe. In vitro
testing demonstrated a significant reduction in microbial growth associated with
catheter-related bloodstream infections (CRBSIs).

Earlier this year, Schott Pharma launched its Toppac Freeze pre-fillable
syringes for delivering deep-cold drugs. Deep-cold drugs are stored and
transported on dry ice at temperatures reaching -100°C.

Schott designed the syringes using an advanced, pharmaceutical-grade polymer,
delivered in a standardized nest-and-tub configuration. This ensures
compatibility on major fill-finish lines to simplify the filling process.

Schott used cyclic olefin copolymer (COC), a break-resistant, biologically inert
material that has advanced barrier properties to ensure drug stability. Its
scientific data package features data on container closure integrity,
functionality and particulate generation after freeze and thaw cycles.


STEVANATO GROUP’S ON-BODY DRUG DELIVERY SYSTEM

In March, Stevanato Group announced plans to bring an on-body drug delivery
device to market through a collaboration with Thermo Fisher Scientific. The
companies intend to offer the platform as an integrated device and
fill-and-finish solution.



The Vertiva on-body delivery system [Image courtesy of Stevanato Group]Stevanato
unveiled the device last month, calling the patented, on-body drug delivery
system “Vertiva.”



Stevanato Group designed Vertiva with the ability to switch between basal and
bolus injections and said it is suitable for a wide range of subcutaneous
therapies. The system’s single-use pod has a pre-filled, pre-loaded 3mL ISO
cartridge. It also comes with a multi-use controller for potential
sustainability and affordability benefits. Both parts communicate through a
patented, magnetically coupled drive mechanism.

Stevanato Group said its device can adapt to different delivery profiles and
enable the administration of small-molecule drugs and biologics. The company has
the design under development to cover a broad range of volumes up to 10mL.

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device
Combinations, Featured, Pharmaceuticals, Technology Tagged With: BD, Beta
Bionics, biocorp, Humacyte, Innovation Zed, Insulet, Juvenile Diabetes Research
Foundation (JDRF), Micron Biomedical, mit, Schott Pharma, Sernova Inc, Stevanato
Group, Tandem Diabetes Care, tidepool, Vivani Medical, Ypsomed


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IN CASE YOU MISSED IT

 * Abbott Diabetes business booms in Q2, company set to submit new sensor in
   U.S. this year
 * 8 drug delivery innovations you should know
 * Ascensia Diabetes Care inks deal to integrate blood glucose monitors in
   point-of-care testing
 * Eitan Medical appoints new CFO
 * This biodegradable brain implant delivers cancer-treating drugs

ABOUT SEAN WHOOLEY

Sean Whooley is an associate editor who mainly produces work for MassDevice,
Medical Design & Outsourcing and Drug Delivery Business News. He received a
bachelor's degree in multiplatform journalism from the University of Maryland,
College Park. You can connect with him on LinkedIn or email him at
swhooley@wtwhmedia.com.


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